Concepta receives CE-Mark certification for 'myLotus' product

29th Oct 2018 15:21

(Sharecast News) - Healthcare company Concepta has received CE-Mark certification for its 'myLotus' branded products for women's fertility, it announced on Monday.The AIM-traded firm said that, given the "stringent regulatory environment" for diagnostics, CE certification was a "major milestone" enabling it to sell its fertility test device 'myLotus' in the UK market, and subsequently across CE-Mark territories.It said myLotus allowed women the ability to self-test to identify their optimal fertile days, thereby improving their chances of naturally getting pregnant.The product enabled women to monitor their fertile phase as part of their menstrual cycle, and was said to be the only home test to "quantitatively" measure personalised hormone levels and the 'rate-of-change' of those levels preceding ovulation, to help aid a natural conception.Users measured, recorded and tracked their hormone levels and followed their fertility journey in an accompanying free downloadable app. The company said it expected to launch its new fertility products under the brand name 'myLotus', with initial demand serviced via its new online retail platform and website.Concepta said the product would be available to women who were planning to start a family, or for those who had previously struggled to naturally conceive, enabling couples an alternative prior to considering more costly IVF treatment."Following several years of diligent work by our technology team, study doctors and trial users we are delighted to receive CE-Mark certification for our first myLotus products," said Concepta chairman Matthew Walls."Novel self-test diagnostics for home-use is a highly regulated field of healthcare and this is a fabulous and eagerly awaited endorsement for the company."Importantly, the certification signals our drive to help improve the chances of women naturally getting pregnant and our preparations for the launch of myLotus in the UK and other CE-Mark territories."